Is Insulin degludec + Liraglutide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Insulin degludec + Liraglutide, including XULTOPHY 100 U/ml + 3.6 mg/ml Solution for Injection (100,3.6 U/ml,mg/ml, Solution for injection, SAR 821.30).

Is Insulin degludec + Liraglutide approved by the US FDA?

Drugs@FDA lists 1 application product line for Insulin degludec + Liraglutide, including XULTOPHY 100/3.6 (Prescription).

Is Insulin degludec + Liraglutide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Insulin degludec + Liraglutide: Xultophy.

Active substances

Insulin degludec + Liraglutide

SFDA 1
US FDA 1
EMA 1
US price lines 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
XULTOPHY 100 U/ml + 3.6 mg/ml Solution for Injection	100,3.6 U/ml,mg/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 821.30	Biological · Prescription	NOVO NORDISK	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XULTOPHY 100/3.6	300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)	solution · subcutaneous	NOVO	Prescription	21 Nov 2016

EMA European Union — centrally authorised medicines

Xultophy Novo Nordisk A/S · Authorised · authorised 18 Sep 2014 · ATC A10AE56

Therapeutic indication (EMA)

Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	XULTOPHY 100 UNIT-3.6 MG/ML PEN	$85.88557	per ML	23 Sep 2026
NHS Drug Tariff	Insulin degludec 100units/ml / Liraglutide 3.6mg/ml solution for injection 3ml pre-filled disposable devices	£95.53	3 pre-filled disposable injection	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.